Cleared Traditional

TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) (K220152) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220152 · Hong Qiangxing (Shenzhen) Electronics Limited · Neurology device
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Apr 2022
Decision
90d
Days
Class 2
Risk

K220152 is an FDA 510(k) clearance for the TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555). Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Hong Qiangxing (Shenzhen) Electronics Limited (Shenzhen, CN). The FDA issued a Cleared decision on April 19, 2022 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hong Qiangxing (Shenzhen) Electronics Limited devices

Submission Details

510(k) Number K220152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2022
Decision Date April 19, 2022
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NUH Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Temporary Relief Of Pain Due To Sore/aching Muscles
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Shanghai CV Technology Co., Ltd.
Doris Dong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 133
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K220152.
Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
K221384 · Hivox Biotek, Inc. · Jun 2022
TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
K213788 · Dongguan Bohuikang Technology Co.,Ltd · May 2022
TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
K220283 · Hong Qiangxing (Shenzhen) Electronics Limited · May 2022
Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
K212377 · Ningbo Medkinetic Medical Device Co., Ltd. · Apr 2022
TENS and EMS Stimulation (OTC)
K212184 · Changsha Yuwen Medical Equipment Co., Ltd. · Apr 2022
TENS & PMS Unit
K220005 · Shenzhen Yuehua Xinsen Technology Co., Ltd. · Apr 2022